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Table 2 Application of MSC-based therapy in IBD clinical trials

From: Mesenchymal stem cell–gut microbiota interaction in the repair of inflammatory bowel disease: an enhanced therapeutic effect

IBD typeStudy designMSC sourceOutcomeReferences
Moderate to severe UCPhase I/II randomized controlled studyHuman umbilical cord30/36 patients showed good response with markedly improved mucosa at 1 month
Decreased median Mayo score and histology score during follow up
No evident adverse reactions after MSC infusion
[53]
CDRandomized controlled studyHuman umbilical cordDecreased CDAI, HBI, and corticosteroid dosage with remarkable mucosal recovery at 12 months
Concomitant anal fistula was improved in six patients treated with MSC
[54]
Luminal CD refractory to biologic therapyPhase 2, open-label, multicenter studyBone marrowImproved recovery associated with reduced CDAI and CDEIS scores
7/15 patients had a clinical response, 8/15 had clinical remission, and 7/15 had endoscopic improvement
[55]
Complex perianal fistulas in CDPhase 3 randomized double-blind controlled trialAdipose53/107 (50%) of MSC treated patients achieved combined remission in intention-to-treat protocol
53/103 (51%) of modified intention-to-treat populations achieved combined remission
[48]
UCTwo years observation after MSC treatmentBone marrow72.7% of UC patients who received MSC treatment achieved significant response
Reduced activity of autoimmune inflammation and stimulated reparative process in the intestinal mucosa
Increased duration of remission, reduced risk of recurrence of disease, and reduced frequency of hospitalizations
[56]
UCBone marrowIncreased in the duration of remission in patients with chronic recurrent and continuous recurrent course of UC
Reduced risk of relapse, and reduced frequency of hospital admissions compared with medication therapy
[57]
Crohn’s perianal fistulaMSC safety study in pregnancyAdiposeFertility and pregnancy outcomes were not affected by MSC treatment
No signs of treatment-related malformations were observed in the neonates by their respective pediatricians
[58]
  1. Summary of some of the IBD clinical trials on the feasibility, safety and efficacy of MSC therapy. Different study designs across varying degrees and types of IBD employing distinct techniques and sources of MSC yielded different patients’ responses
  2. CDAI Crohn’s disease activity index, HBI Harvey–Bradshaw index, CDEIS Crohn’s disease endoscopic index of severity